Back to resultsAn Exploratory Investigation of a Supplement to Promote Brain Health
Primary Purpose
Memory Deficits, Cognitive Change, Stress
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Daily Supplement
Sponsored by
About this trial
This is an interventional other trial for Memory Deficits focused on measuring Focus, Memory, Attention, Stress
Eligibility Criteria
Inclusion Criteria:
- In good general health with no major chronic conditions (e.g., diabetes, coronary heart disease, etc.)
Exclusion Criteria:
- Females who are pregnant or breastfeeding
- Anyone currently taking other supplements
- Anyone with a known allergic reaction
- Previous head trauma
- Anyone with chronic diseases such as diabetes, coronary heart disease, or cancer.
- Any psychological, mental, or neurodevelopmental disorders
- Consumes nicotine or marijuana in any form
- Previous or current alcohol addiction
- Consume more than 10 drinks per week
Sites / Locations
- Citruslabs
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The Daily Supplement
Arm Description
Participants will use test product daily, and complete Biomarker assessments (at 1st dose, Day 7, Day 31), as well as surveys (at 1st dose, Day 7, Day 31), and Cognitive battery Assessments (at 1st dose, Day 7, Day 31).
Outcomes
Primary Outcome Measures
Perceived changes in mental health symptoms as measured by Questionnaires
Questionnaires measure perceived changes in mental health symptoms (e.g., anxiety levels, mental clarity) and stress management on a scale of 0 (low levels of mental health symptoms) to 10 (very high levels of mental health symptoms)
Perceived changes in stress management as measured by Questionnaires
Questionnaires measure perceived changes in stress management on a scale of 0 (poor ability to manage stress) to 10 (excellent ability to manage stress)
Secondary Outcome Measures
Changes in Cognitive Functioning
Cognitive battery questionnaires measure executive functioning, long term memory, working memory, and attention.
Full Information
NCT ID
NCT05520424
First Posted
August 26, 2022
Last Updated
August 29, 2022
Sponsor
Parable
Collaborators
Citruslabs
1. Study Identification
Unique Protocol Identification Number
NCT05520424
Brief Title
An Exploratory Investigation of a Supplement to Promote Brain Health
Official Title
An Exploratory Investigation of a Supplement to Promote Brain Health
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 15, 2022 (Actual)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Parable
Collaborators
Citruslabs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Providing a combination of synergistic dietary supplements, such as vitamins B6, B12, and folate, as well as curcumin, lemon balm, and American ginseng is hypothesized to promote brain health and aid with brain fog, mental clarity, ability to handle stress, mood, focus, and productivity, as well as promote overall well-being.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Deficits, Cognitive Change, Stress
Keywords
Focus, Memory, Attention, Stress
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The Daily Supplement
Arm Type
Experimental
Arm Description
Participants will use test product daily, and complete Biomarker assessments (at 1st dose, Day 7, Day 31), as well as surveys (at 1st dose, Day 7, Day 31), and Cognitive battery Assessments (at 1st dose, Day 7, Day 31).
Intervention Type
Dietary Supplement
Intervention Name(s)
The Daily Supplement
Intervention Description
The ingredient list of the product includes the following:
400mg of curcumin (Longvida) 300mg of lemon balm extract (Cyracos) 200mg of American ginseng (Cereboost) 50mg of epigallocatechin gallate derived from green tea Organic oat milk powder Phosphatidylserine (SerinAid) (active) B6 (in the form of P5P) Folate (Quatrefolic) B12 Silica (non-active)
Primary Outcome Measure Information:
Title
Perceived changes in mental health symptoms as measured by Questionnaires
Description
Questionnaires measure perceived changes in mental health symptoms (e.g., anxiety levels, mental clarity) and stress management on a scale of 0 (low levels of mental health symptoms) to 10 (very high levels of mental health symptoms)
Time Frame
31 days
Title
Perceived changes in stress management as measured by Questionnaires
Description
Questionnaires measure perceived changes in stress management on a scale of 0 (poor ability to manage stress) to 10 (excellent ability to manage stress)
Time Frame
31 days
Secondary Outcome Measure Information:
Title
Changes in Cognitive Functioning
Description
Cognitive battery questionnaires measure executive functioning, long term memory, working memory, and attention.
Time Frame
31 days
Other Pre-specified Outcome Measures:
Title
Changes in plasma/serum biomarkers associated with brain health
Description
Biomarkers collected via. blood sample sent to a third party lab. The biomarkers of interest for this trial include hs-CRP, HbA1c, homocysteine, and IL-6.
Time Frame
31 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
In good general health with no major chronic conditions (e.g., diabetes, coronary heart disease, etc.)
Exclusion Criteria:
Females who are pregnant or breastfeeding
Anyone currently taking other supplements
Anyone with a known allergic reaction
Previous head trauma
Anyone with chronic diseases such as diabetes, coronary heart disease, or cancer.
Any psychological, mental, or neurodevelopmental disorders
Consumes nicotine or marijuana in any form
Previous or current alcohol addiction
Consume more than 10 drinks per week
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Hill, PhD
Organizational Affiliation
Citruslabs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
An Exploratory Investigation of a Supplement to Promote Brain Health
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